Back to resultsA Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
Primary Purpose
Esophageal Neoplasms
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Esophagectomy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Esophageal neoplasms, Esophagectomy
Eligibility Criteria
Inclusion Criteria:
- Patients with cT2-T3/N0-N1-M1a-M1b(lymph node metastasis only) esophageal squamous cell and adenocarcinoma who have potentially resectable disease.
- Karnofsky performance status greater than or equal to 80%.
- Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
- Acceptable hepatic, renal and bone marrow function.
- Age 18 or older.
- Patients may receive preoperative chemotherapy and/or radiation therapy as part of their clinical care.
Exclusion Criteria:
- Patients with clearly unresectable or metastatic esophageal cancer or clinical stage I esophageal cancer.
- Significant psychiatric illness that would interfere with patient compliance.
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
- Patients with a significant history of unstable cardiovascular disease (e.g., inadequately controlled hypertension, or angina; myocardial infarction within the previous 6 months; ventricular cardiac arrhythmias requiring medication; congestive heart failure that in the opinion of the treating physician should preclude the patient from protocol treatment.
- Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
Sites / Locations
- Weill Medical College of Cornell Unversity
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
En bloc esophagectomy is performed through a transthoracic approach by removing the tumor-bearing esophagus, the pericardium anteriorly, both pleural surfaces laterally, as well as the thoracic duct and all other lymphoareolar tissue wedged posteriorly between the esophagus and the spine, and en-bloc resection of all nodal groups in the middle and lower mediastinum as well as the upper abdomen.
Transhiatal esophagectomy is performed through an abdominal incision and a neck incision. The stomach is mobilized, and the left gastric vessels are transected at its origin. Celiac lymph nodes are dissected, and the intrathoracic esophagus is dissected bluntly through the hiatus and through the neck. The cervical esophagus is divided at the level of the neck. After the esophagogastrectomy is performed, a gastric tube is created. An esophagogastrostomy is then performed in the neck. If a transthoracic approach is used, dissection will be as described for the transhiatal approach.
Outcomes
Primary Outcome Measures
Disease free survival defined as the time from surgical resection to the time of recurrent disease, death from esophageal cancer, or death from any cause.
Secondary Outcome Measures
To determine 5-year overall and disease-specific survival in arm A and arm B
To determine the rates of local and systemic recurrence in arm A vs. arm B
To determine time to progression in arm A vs. arm B
To determine mortality and morbidity in arm A vs. arm B
Full Information
NCT ID
NCT00760604
First Posted
September 25, 2008
Last Updated
August 10, 2012
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00760604
Brief Title
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
Official Title
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Closed due to slow patient accrual.
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test 2 different methods of surgery to remove cancer in the esophagus. This research is being done to see whether removing more tissue and lymph nodes surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc esophagectomy).
Detailed Description
The aim of this study is to determine the 5-year disease-free survival, overall survival, and time to progression comparing (Arm A) transthoracic en bloc esophagectomy and (Arm B) transhiatal or transthoracic non-en bloc esophagectomy. Randomization to the two surgical arms will take place after the patient has given written informed consent and eligibility has been established. Patients will be informed of their randomized arm prior to the day of surgery. Preoperative chemotherapy may be administered at the discretion of the treating physician. Adjuvant chemotherapy and/or radiotherapy will be prescribed at the discretion of the treating physician. All patients will be followed for recurrence and survival for 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms
Keywords
Esophageal neoplasms, Esophagectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
En bloc esophagectomy is performed through a transthoracic approach by removing the tumor-bearing esophagus, the pericardium anteriorly, both pleural surfaces laterally, as well as the thoracic duct and all other lymphoareolar tissue wedged posteriorly between the esophagus and the spine, and en-bloc resection of all nodal groups in the middle and lower mediastinum as well as the upper abdomen.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Transhiatal esophagectomy is performed through an abdominal incision and a neck incision. The stomach is mobilized, and the left gastric vessels are transected at its origin. Celiac lymph nodes are dissected, and the intrathoracic esophagus is dissected bluntly through the hiatus and through the neck. The cervical esophagus is divided at the level of the neck. After the esophagogastrectomy is performed, a gastric tube is created. An esophagogastrostomy is then performed in the neck. If a transthoracic approach is used, dissection will be as described for the transhiatal approach.
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Intervention Description
Comparison of en-bloc vs. non-en bloc esophagectomy
Primary Outcome Measure Information:
Title
Disease free survival defined as the time from surgical resection to the time of recurrent disease, death from esophageal cancer, or death from any cause.
Time Frame
CT scans will be performed every 6 months for 5 years.
Secondary Outcome Measure Information:
Title
To determine 5-year overall and disease-specific survival in arm A and arm B
Time Frame
CT scans every 6 months for 5 years
Title
To determine the rates of local and systemic recurrence in arm A vs. arm B
Time Frame
CT scans performed every 6 months for 5 years
Title
To determine time to progression in arm A vs. arm B
Time Frame
CT scans every 6 months for 5 years
Title
To determine mortality and morbidity in arm A vs. arm B
Time Frame
5 years from the date of surgical resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with cT2-T3/N0-N1-M1a-M1b(lymph node metastasis only) esophageal squamous cell and adenocarcinoma who have potentially resectable disease.
Karnofsky performance status greater than or equal to 80%.
Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
Acceptable hepatic, renal and bone marrow function.
Age 18 or older.
Patients may receive preoperative chemotherapy and/or radiation therapy as part of their clinical care.
Exclusion Criteria:
Patients with clearly unresectable or metastatic esophageal cancer or clinical stage I esophageal cancer.
Significant psychiatric illness that would interfere with patient compliance.
Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
Patients with a significant history of unstable cardiovascular disease (e.g., inadequately controlled hypertension, or angina; myocardial infarction within the previous 6 months; ventricular cardiac arrhythmias requiring medication; congestive heart failure that in the opinion of the treating physician should preclude the patient from protocol treatment.
Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul C Lee, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell Unversity
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
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